FDA WARNING_LETTER - Yogi's Vape - March 15, 2022

On March 15, 2022, the FDA issued a Warning Letter to Yogi’s Vape for manufacturing and distributing e-liquid products, specifically Yogi’s Legend Berry 3mg e-liquid, without required premarket authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007.

The identified product, Yogi’s Legend Berry 3mg e-liquid, lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

Yogi’s Vape is a registered manufacturer with over 31,300 products listed. A Premarket Tobacco Product Application (PMTA), STN PM0003759, submitted on September 2, 2020, received a Marketing Denial Order on September 9, 2021, covering 24,760 products.

The FDA requires prompt action to address these